We’re not enforcing NDI draft guidance; GMPs are the biggest issue
date:May 11, 2012
It won't be the last time we use those authorities,said Fabricant.It's something to be mindful of. It's something we take very seriously, as you've seen from the actions.


The increase in inspections has been followed by a significant uptick in the number of warning letters for GMP violations: In 2010, FDA issued 8 letters regarding GMP violations. In 2011, that number quadrupled, with 34 companies being cited for a wide range of violations from failure to establish product specifications to f
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12/29 04:01